By Jen Christensen, CNN (CNN) – The US Food and Drug Administration warns patients for a recall of medicines used…
By Jen Christensen, CNN
(CNN) – The US Food and Drug Administration warns patients for a recall of medicines used to treat high blood pressure, for a potential risk of cancer due to contamination. This time, SciGen recalls some much irbesartan.
The recalled part will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, according to the FDA list.
Another cardiac medicine, valsartan, has also been recalled recently because of contamination.
Irbesartan is an angiotensin II receptor blocker or ARB. This is a drug that blocks a potent chemical in the blood called anigiotensin, which causes muscles surrounding the blood vessels to contract from binding with angiotensin II receptors. When the chemical binds, it lowers the vessels and it can cause high blood pressure.
FDA tests showed that they recalled the masses of these drugs contained N-nitrosoethylethyl or NDEA, a suspected human and animal carcinogen used in petrol as a stabilizer for industrial materials and as a lubricant additive by the National Institute of Health.
This is the first non-valsartan drug product that the agency has found to contain NDEA pollutants.
Several pills containing valsartan have been recalled since July. The drugs were troubled with NDEA or NDMA, N-nitrosodimethylamine, a impurity that is also considered a potentially carcinogenic substance by the US Environmental Protection Agency.
NDMA is an organic chemical used to produce liquid rocket fuel and a by-product to produce some pesticides and process fish. It may inadvertently be introduced into manufacturing through certain chemical reactions.
The FDA tests all ARB for these pollutants. It had to design a special test after learning that some ingredients imported from a company in China, Zhejiang Huahai Pharmaceuticals, were troubled.
The FDA placed Zhejiang Huahai Pharmaceuticals in an import alert at the end of September, meaning that all active drugs Products and finished products manufactured by the company will not be allowed to enter the United States. The FDA took the decision after the newly inspected facility.
Aurobindo, which is the ingredient of ScieGens irbesartan products, retrieves all unexpected parts of the Irbesartan API that are delivered to the US market with NDEA. FDA and Aurobindo laboratory tests confirmed NDEA in some parts of their irbesartan API.
All medicines containing valsartan or irbesartan are not recalled. This recall affects about 1
% of the Irbesartan drug products on the US market, according to the FDA.
Talk to your doctor or pharmacist before changing any medicine. Since not all valsartan and irbesartan drugs are involved in the recall, you may be able to switch to a version of another company. The FDA keeps a second list of valsartan products that are not recalled.
If your medicine is on the recall list, the FDA suggests that you take it until your doctor or pharmacist gives a replacement.
It is unclear exactly what the cancer risk is if you are taking contaminated valsartan or irbesartan pills; The FDA thought the risk was low with the valsartan recall. It is estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) containing NDMA from these withdrawn rates daily for four years, there may be a further case of cancer during the lifespan of 8,000 people. Many patients take a much lower dose of valsartan, and therefore their risks theoretically are much lower.
The FDA said it continues to test all products containing valsartan and similar drugs for contamination.
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